Merck Sharp & Dohme: Remicade ad strapline “more than a name” implied special merit without substantiation (AUTH/2923/12/16)

📅 2016 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/2923/12/16
CompanyMerck Sharp & Dohme Limited
ComplainantHospital pharmacist
MedicineRemicade (infliximab)
MaterialTwo-page journal advertisement (ref RHEU-1191218-0001); prescribing information on page two
PublicationThe Pharmaceutical Journal (between October and December 2016)
Key claims/strapline“August 2016”; “17 years of Clinical Experience with over 2.4 Million Patients treated worldwide”; strapline “more than a name”
Applicable Code year2016
Complaint received20 December 2016 (PDF) / 21 December 2016 (HTML listing)
Case completed7 August 2017
Panel decisionNo breach (all alleged clauses)
AppealAppeal by complainant; successful in part
Final breachesClause 7.2; Clause 7.10
No breach clausesClauses 2, 3.2, 7.8, 9.1, 9.7
SanctionsUndertaking received; additional sanctions not stated

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Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

  • A hospital pharmacist complained about a two-page Remicade (infliximab) advertisement by Merck Sharp & Dohme, published in The Pharmaceutical Journal (Oct–Dec 2016).
  • Page 1 featured an intact dandelion seed head image with the date “August 2016”, the claim “17 years of Clinical Experience with over 2.4 Million Patients treated worldwide” (referenced to data on file), and the Remicade logo incorporating the strapline “more than a name” (also referenced to data on file).
  • The complainant alleged the imagery could imply an allergy/hay fever indication (disguised promotion/off-label implication), that “August 2016” and the experience/patient-number claim were meaningless/confusing, and that “more than a name” was an unsubstantiated hanging comparison/superlative implying superiority.
  • MSD said the “dandelion clock” symbolised passage of time and “August 2016” marked the 17-year anniversary of first marketing authorisation (Aug 1999); it argued the strapline was not comparative and that prescribing information was provided overleaf.
  • The Panel initially ruled no breach on all points, but the complainant appealed.
  • On appeal, the Appeal Board reviewed the “data on file” (PSUR excerpt) which contained only a brief exposure figure (2,437,109 from launch in 1998 to Aug 2015) and no efficacy/safety data.
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Outcome

  • Breach found (on appeal): Clauses 7.2 and 7.10.
  • No breach: Clauses 2, 3.2, 7.8, 9.1, 9.7.
  • The Appeal Board concluded the strapline “more than a name” implied Remicade was more than infliximab and suggested special merit versus other infliximabs, which was not substantiated by the referenced data on file.
  • The Appeal Board also found the claim/strapline was ambiguous and the referenced data on file was not sufficiently complete to allow readers to form their own opinion on therapeutic value.
  • Additionally, given the exaggeration/ambiguity, the advertisement failed to promote the rational use of Remicade and did not present it objectively (further breach of Clause 7.10), despite prescribing information being provided overleaf.
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